MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EXTRA VIEW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMS-XB1
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic prostatectomy, the balloon burst while making of space in cavity.Fragments of the balloon were in the patient's cavity.Surgeons were able to remove the fragments but not sure if all were retrieved.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic prostatectomy, the balloon burst while making of space in cavity.Fragments of the balloon were in the patient's cavity.Surgeons were able to remove the fragments that were retrieved using grasper.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the balloon, obturator, valve seal and doors appeared intact.The inflation syringe and obturator were received.A functional evaluation found that the balloon was inflated, a leak was detected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cut in the balloon may occur when mishandled during clinical application.As per instructions for use (ifu), caution : care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTRA VIEW
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9762650
• Report Number: 2647580-2020-00733
• Device Sequence Number: 18958744
• Product Code: GCJ
• UDI-Device Identifier: 10884521068025
• UDI-Public: 10884521068025
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K954175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: OMS-XB1
• Device Catalogue Number: OMS-XB1
• Device Lot Number: P7J1348X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 04/14/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/02/2020; 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention